Chimerix has received FDA clearance for its investigational new drug application for CMX001, the company's oral antiviral drug candidate for the treatment of smallpox infections and complications resulting from smallpox vaccine.
Chimerix will initiate a single-site Phase I clinical trial to evaluate the safety of CMX001 in healthy volunteers. CMX001 has been used to treat orthopox virus infections, a viral class which includes the smallpox virus, in animal models. CMX001 is being developed in partnership with the U.S. National Institute of Allergy and Infectious Diseases of the NIH under a $36.1 million grant that was awarded to Chimerix in September 2003.